Evaluation of the effect of a toothpaste containing Pudilan extract on inhibiting plaques and reducing chronic gingivitis: A randomized, double-blinded, parallel controlled clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Pudilan is a famous traditional Chinese medicine compound which contains several Chinese herbal ingredients, and has been wildly used to treat a variety of inflammatory diseases in China. Recently, it was reported that Pudilan extract had been used in the oral field, especially in the treatment of minor oral ulcers for its anti-inflammatory, pain relieving, antibacterial, clearing heat, and detoxifying effects. AIM OF THE STUDY: To evaluate the effectiveness and safety of Pudilan extract-containing toothpaste in controlling plaques and reducing chronic gingivitis. MATERIALS AND METHODS: A total of 120 patients with chronic gingivitis were randomized into an experiment group and a control group (n = 60 patients per group) based on a double-blinded method. Patients in the experiment group used a Pudilan extract-containing toothpaste, whereas patients in the control group used a Pudilan toothpaste simulator, which were identical as the toothpaste used by the experiment group, except for not containing the Pudilan extract. The Plaque Index (PI), Gingival Index (GI), Bleeding Index (BI), and Bleeding On Probing proportion (BOP%) were recorded at baseline, 4 weeks, 8 weeks and 12 weeks after using the toothpaste. RESULTS: After using the toothpaste for 8 and 12 weeks, PI, BI, GI, and BOP% of the experiment group were significantly lower when compared to the control group (both p < 0.001). Moreover, after using the toothpaste for 4, 8, and 12 weeks, the decline of the PI and GI in the experiment group were significantly higher than the control group (p < 0.001, except 4weeks PI p = 0.011). After 12 weeks, the PI of the experiment group decreased 35.73% (p < 0.001) whereas the GI decreased 29.04% (p < 0.001). BI and BOP decline rates were statistically significant when compared to those of the control group at 8 and 12 weeks (both p < 0.001). Moreover, at 12 weeks, the BI of the experiment group decreased 34.33% (p < 0.001) and BOP% decreased 54.71% (p < 0.001). CONCLUSION: Toothpaste with Pudilan extract demonstrated good effect on relieving symptoms of chronic gingivitis by inhibiting plaque formation, reducing gingival inflammation and the degree of bleeding, and the bleeding rate. Toothpaste containing Pudilan extract has prospective application potentials in the prevention and treatment of chronic gingivitis.